IOGYN SYSTEM

Insufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar

IOGYN, INC.

The following data is part of a premarket notification filed by Iogyn, Inc. with the FDA for Iogyn System.

Pre-market Notification Details

Device IDK141848
510k NumberK141848
Device Name:IOGYN SYSTEM
ClassificationInsufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar
Applicant IOGYN, INC. 20195 STEVENS CREEK BOULEVARD SUITE 120 Cupertino,  CA  95014
ContactRich Christensen
CorrespondentRich Christensen
IOGYN, INC. 20195 STEVENS CREEK BOULEVARD SUITE 120 Cupertino,  CA  95014
Product CodePGT  
CFR Regulation Number884.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-09
Decision Date2014-08-29
Summary:summary

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